HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER— 510(k) K082129
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K082129 for HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER, Substantially Equivalent on 2009-02-10. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Recent devices under product code CFN
view allMore clearances from The Binding Site, Ltd.
view all- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- K083289 — HUMAN BETA-2 MICROGLOBULIN KIT
- K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
Recalls naming K082129
K-number listed on FDA's recall record- Z-0604-2019 — Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
- Z-0477-2019 — Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082129.
Data sourced from openFDA. This site is unofficial and independent of the FDA.